贝佐洛托珠单抗预防复发性艰难梭菌感染：来自随机 III 期试验 MODIFY II 的 12 个月观察数据。
Bezlotoxumab for the Prevention of Recurrent Clostridioides difficile Infection: 12-Month Observational Data From the Randomized Phase III Trial, MODIFY II.
机构信息
R. M. Alden Research Laboratory, Santa Monica, California, USA.
Hines Veterans Affairs Hospital, Hines, Illinois, USA.
出版信息
Clin Infect Dis. 2020 Aug 14;71(4):1102-1105. doi: 10.1093/cid/ciz1151.
From Monoclonal Antibodies for C. difficile Therapy II, no participants (n = 0/69) with a sustained clinical cure through 12 weeks following bezlotoxumab infusion experienced recurrent Clostridioides difficile infection (rCDI) after 9 months (versus actoxumab + bezlotoxumab, n = 2/65; versus placebo, n = 1/34). Bezlotoxumab's efficacy appears to be due to prevention rather than delayed onset of rCDI. Clinical Trials Registration. NCT01513239.
从抗艰难梭菌治疗的单克隆抗体 II 期临床试验来看，贝洛妥珠单抗输注后 12 周持续临床治愈的患者（n=0/69），在 9 个月后（n=2/65，与 actoxumab+bezlotoxumab 组相比；n=1/34，与安慰剂组相比）并未出现复发性艰难梭菌感染（rCDI）。贝洛妥珠单抗的疗效似乎是通过预防而不是延迟 rCDI 的发生来实现的。临床试验注册。NCT01513239。
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